Kornimate/medical-research-clean huggingface dataset:
early detection & intervention of cerebral palsy in ireland

Conditions: Cerebral Palsy; Neurodevelopmental Disorders

Summary: cerebral palsy (cp) is the most common lifelong physical disability. it is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. these include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. people with cp often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. however, in most clinical settings, the age for diagnosis of cp is between 24 to 29 months, after this window of neurodevelopmental opportunity. this project will aim to improve the early detection of cerebral palsy in ireland. this will be achieved by implementing an evidence-based approach to follow-up of high risk infants.


Eligibility criteria:
inclusion criteria: * legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol. * all infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including: * all preterm infants born ≤32 weeks post menstrual age or ≤1500 gm birth weight * all encephalopathic infants * neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam) exclusion criteria: * death prior to discharge from the neonatal unit.
fcn-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas

Conditions: Neurofibromatosis 1; Plexiform Neurofibroma; NF1

Summary: a study to evaluate the efficacy of fcn-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.

this is a randomized, double-blind, placebo-controlled, multi-center phase iii clinical study to evaluate the efficacy and safety of fcn-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old and ≤ 70 years old. 2. patients must be diagnosed with symptomatic nf1-related plexiform neurofibromas (pns) and require systemic therapy at the investigator's discretion. 3. presence of measurable lesions, defined as ≥ 3 cm in length in at least one dimension, which can be evaluated for efficacy by mri. 4. karnofsky performance status score ≥ 70. 5. patients with adequate organ and bone marrow functions. exclusion criteria: 1. nf1-related malignancies requiring chemotherapy, radiotherapy, or surgery, such as medium to high grade optic glioma or malignant peripheral nerve sheath tumor. 2. patients with a history of or concurrently with other malignancies (excluding cured non-melanoma skin basal cell carcinoma, breast cancer in situ or cervical cancer in situ, and other malignancies without evidence of disease within 5 years). 3. patients who cannot undergo mri and/or have contraindications to mri. 4. patients with previous or current retinal vein obstruction (rvo), retinal pigment epithelial detachment (rped), glaucoma, and other abnormal ophthalmic examination with clinical significance. 5. interstitial pneumonia, including clinically significant radiation pneumonia. 6. cardiac function or combined diseases meet one of the following conditions: 1. qtcf value of \> 470 milliseconds; patients with risk factors for qtcf prolongation or patients receiving drugs that prolong the qtcf interval. 2. congestive heart failure per new york heart association (nyha) classification ≥ class 3. 3. arrhythmias with clinical significance. 4. known concurrent clinically significant coronary artery disease, cardiomyopathy, and severe valvular disease. 5. lvef \< 50%. 6. patients with a heart rate of \< 50 beats/min.
postpartum pre-exposure prophylaxis (prep) study to evaluate an adherence promotion package for postpartum women on prep

Conditions: HIV-1-infection

Summary: the postpartum prep study (pps) seeks to evaluate how best to improve adherence to prep in postpartum women and to evaluate how acceptable it is to offer hiv self tests for the participant and partner, and provide enhanced adherence biofeedback following a urine test of recent prep use (measuring tenofovir). the primary outcome is recent prep adherence following the intervention. the secondary outcome is hiv testing uptake in participants' partners.

pregnant and breastfeeding women in south africa are at very high risk of hiv acquisition and vertical hiv transmission during pregnancy, labour and breastfeeding. one-third to half of perinatal hiv transmission occurs in women who are seroconvert during the pregnancy and post-partum period. effective use of pre-exposure prophylaxis (prep) could contribute to eliminating maternal hiv acquisition, and hence mother to child transmission (mtct) of hiv. however, prep efficacy requires high levels of adherence, and adherence requires high levels of acceptability, yet there are few data on how best to promote adherence to prep in postpartum women. we will conduct a study of the feasibility and acceptability of an adherence promotion package in n=100 postpartum women enrolled in an ongoing prep study (prep-pp; ongoing, r01mh116771) to evaluate the feasibility, acceptability and efficacy of a package of interventions to improve prep adherence in pregnancy and postpartum women. specifically the package of interventions will include: * offer of hiv self-test in women and their partners with counseling on use * integrating urine based lateral flow assays in enhanced counseling using biofeedback on adherence levels to postpartum women on prep the primary outcome is recent prep adherence at 1-month following the intervention. the secondary outcome is hiv testing uptake in participants' partners.

Eligibility criteria:
inclusion criteria: 1. currently enrolled in prep-pp study and on prep 2. 18+ years old 3. confirmed hiv-negative (confirmed with a 4th generation antigen hiv test) 4. confirmed to be postpartum (1-6 months postpartum) 5. confirmed to currently have a male partner 6. confirmed to have a cell phone that can read and respond to sms/whatsapp messages exclusion criteria: failure to meet all of inclusion criteria

Keywords: prep pmtct adherence pregnant postpartum counseling hiv self-testing
self help for fatigue in multiple sclerosis

Conditions: Multiple Sclerosis; Fatigue

Summary: the purpose of this study is to determine if cognitive behavioural therapy (cbt) based self help is effective for the management of symptoms of fatigue in multiple sclerosis (ms).

background: fatigue is a common disabling symptom in patients with multiple sclerosis (ms). cognitive behavioural therapy (cbt) has been shown to be effective in the reduction of fatigue in ms and cbt-based self-help has been shown to be effective as a low intensity intervention for anxiety and depression. objectives: to evaluate the effectiveness of a cbt based self-help workbook at reducing perceived impact of fatigue in a clinical sample of ms patients.

Eligibility criteria:
inclusion criteria: * all participants will be aged 18 or over * will have a recognised diagnosis of relapsing remitting or primary progressive relapsing remitting multiple sclerosis from a neurologist * cognitively able to give informed consent as deemed by referring clinician in the fife rehabilitation service * willing to consent to randomised control trial * fatigue as a primary symptom exclusion criteria: * patients with severe anxiety or depression (assessed by cut off on hads) * patients with psychosis or personality disorders (assessed by referring clinician) * patients currently receiving input from psychological services for fatigue management * patients with suicidal ideation or plans (assessed by referring clinician) * patients who are unable to read the workbook or standardised questionnaires due to literacy levels or cognitive abilities will be excluded from the analysis, although if patients have literacy or cognitive problems, referral to a more suitable 1-to-1 type of therapy will be made.

Keywords: randomised controlled trial multiple sclerosis fatigue cognitive behavioural therapy self help
[68ga]ga-pentixafor pet/ct in acute myocardial inflammation

Conditions: Acute Cellular Graft Rejection; Cardiac Sarcoidosis; Myocarditis Due to Drug

Summary: acute myocardial inflammation is an heterogenic syndrome involving different clinical pathologies with different outcome. for the purpose of this study protocol, we focuse on three entities of this syndrome, namely the acute cellular cardiac allograft rejection (acr), cardiac sarcoidosis (cs) and the immune checkpoint inhibitor induced myocarditis (icim), for which non-invasive diagnosis remains challenging. since accurate diagnosis of myocardial inflammation in an early stage is crucial, this study aims to investigate the accuracy of \[68ga\]ga-pentixafor as a marker of for the presence of inflammatory cells (t-lymphocytes and m1) in described patients. the identification of a correlation between \[68ga\]ga-pentixafor myocardial accumulation with currently accepted diagnostic tools would open up new ways to non-invasively diagnose acute myocardial inflammation.

imaging will consist of administration of maximum 50 µg iv pentixafor, labelled with 150 ±15 mbq of 68ga, as bolus injection 60 ±15 minutes prior pet/ct

Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female * age ≥ 18 years * patients with suspicion cs (group ii) or icim (group iii) or in their regular follow-up in their first year after ht (group i) * soc clinical follow-up at the cardiology department in chuv. exclusion criteria: the presence of any one of the following exclusion criteria will lead to exclusion of the participant: * absence of a signed written informed consent * patients aged \< 18 years * claustrophobia * myocardial ischemia in non-invasive perfusion test or coronarography in group ii and iii * clinically unstable cardiovascular conditions, including: * clinically unstable brady-tachyarrhythmia * severe and symptomatic hypo- or hypertension with documented systolic blood pressure \< 90 mmhg or ≥220 mmhg respectively * cardiogenic shock. * women who are pregnant or breast feeding * intention to become pregnant during the course of the study in group ii * previous enrolment into the current study * moderate to severe renal insufficiency (gfr \< 45 ml/min/1,73 m2), with contra-indication to the administration of gadolinium in group ii and iii * enrollment of the investigator, his/her family members, employees and other dependent persons * history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment * insufficient knowledge of project language, inability to give consent or to follow procedures * the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
primary care pathway for childhood asthma

Conditions: Asthma

Summary: at least half of children with asthma have poor disease control, which can result in complications requiring emergency treatment and hospitalization. as asthma is one of the most common reasons for children to visit emergency departments (ed) and be hospitalized, this disease places a heavy burden on the health care system and families. while there is strong evidence that timely treatment with preventative therapies can substantially improve asthma control, reduce sudden worsening of symptoms, and lower rates of ed visits and hospitalizations, a significant proportion of children do not receive these therapies. the purpose of this study is to improve the prescription and use of evidenced-based preventative therapies for children with asthma with the goal to significantly improve their disease control and quality of life, while reducing unnecessary ed visits and hospitalizations. the investigators will achieve this by: i) installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (emr) to facilitate the use of best-evidence by practitioners, and ii) training chronic disease management (cdm) health professionals to provide targeted and timely asthma education to parents and children with asthma. the investigators will test this pathway and education project in a representative sample of 22 alberta primary care practices, using a pragmatic cluster controlled trial methodology.


Eligibility criteria:
inclusion criteria: * validated diagnosis of asthma according to cpcssn validated definition exclusion criteria: * children under 1 and over 17 years of age * children of parents who have opted out of cpcssn data collection * children with validated asthma who have not attended practices in the last 2 years, or have not received bronchodilator therapy in the last 12 months
role of preoperative carbohydrates drinks, dichloroacetate and exercise on postoperative muscle insulin resistance

Conditions: Insulin Resistance

Summary: the aim of the study is to investigate whether preoperative interventions such as carbohydrate drinks, dichloroacetate and exercise would inhibit or reverse the changes in molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle insulin resistance in patients undergoing major abdominal surgery.

forty patients undergoing open elective gastrointestinal surgery, will be randomized to four groups of 10 each. the patients will be randomised to receive either preoperative (1) oral carbohydrate drinks (cho) or (2) infusion of dichloroacetate with oral carbohydrate drinks (3) exercise or (4) standard care. since the interventions are qualitatively different and only the physiological mechanisms are being studied rather than the clinical outcomes, the study is not blinded and no placebo is used. analysis for cytokines, insulin, glucagon levels will be performed at screening, during surgery and on the 2nd postoperative day. muscle biopsies will be taken at the beginning and end of surgery, from rectus abdominus and vastus lateralis muscles for analysis of mrna (il-6, tnf-α, akt1, irs-1, foxo1, mafbx, murf1 and pdk4) and protein (mafbx, foxo1, pdk4) expression and muscle metabolites (glycogen, lactate, triglycerides and ffa). oral glucose tolerance test (gtt) to be performed at the screening visit and on the 2nd postoperative day using a standard protocol. the techniques to be employed to study the above will include rt-pcr, radioimmunoassay, spectophotometry, bioluminometry, western blotting and elisa. primary outcome: the changes in indices of muscle insulin resistance and muscle protein breakdown at the beginning and at the end of surgery, in response to surgical stress. secondary outcomes: (a) the expression of muscle metabolites, reflecting muscle protein turnover (b) clinical outcomes: length of stay and incidence of postoperative complications.

Eligibility criteria:
inclusion criteria: * all patients over 18 years of age, who are undergoing major elective open abdominal surgery will be included in the study. patients should be able to provide a written informed consent to participate in the study. exclusion criteria: * patients who are 1. undergoing emergency surgery 2. suffering from chronic illness, (e.g. diabetes) or other debilitating diseases 3. on long term anti-inflammatory drugs, (e.g. nsaids, steroids, immunosuppressant) 4. on long term antibiotics 5. on statins 6. on full therapeutic dose of anticoagulants, or aspirin \>325 mg/day, clopidrogel \>75mg/day 7. suffering from bleeding diathesis 8. unable to give consent 9. pregnant or breastfeeding.
combined use of teriparatide and raloxifene in postmenopausal women with osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. the study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.


Eligibility criteria:
inclusion criteria * must be diagnosed with osteoporosis. * must be female, age 45 through 85. * must be at least 5 years postmenopausal. * must be free of other severe or chronically disabling conditions. * must be able to properly use injection device. exclusion criteria * must not have bone diseases other than osteoporosis. * must not have history of certain cancers. * must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes). * must not have taken or are currently taking certain types of medicines. * must not have known allergy to the study agent or serm.
multicenter, prospective, real world study of camrelizumab in cross-line treatment of non-small cell lung cancer

Conditions: NSCLC

Summary: to explore the effectiveness and safety of camrelizumab based cross-line therapy for patients with advanced nsclc in the real world


Eligibility criteria:
inclusion criteria: 1. signed informed consent and volunteered to join the study 2. aged \>=18 years 3. patients with stage iiib, iv, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as egfr/alk- 4. eastern cooperative oncology group (ecog) performance status 0-1 5. at least one measurable lesion (according to recist 1.1) 6. no prior systemic therapy for advanced/metastatic nsclc 7. contraception exclusion criteria: 1. those who are allergic to drug treatment； 2. patients who were also treated with other immunodrugs or therapies； 3. patients who are participating in other intervention studies； 4. patients with other malignant tumors at the same time； 5. pregnant or lactating women； 6. the investigator did not consider the patients eligible to participate in the study under any other circumstances.
safety, efficacy and pharmacokinetics of bta-c585 in a rsv viral challenge study

Conditions: Respiratory Syncytial Virus (RSV) Infection

Summary: the primary purpose of this study is to evaluate the antiviral activity of oral bta-c585 compared to placebo in healthy volunteers after intranasal challenge with rsv-a memphis 37b virus.


Eligibility criteria:
inclusion criteria: 1. healthy male or female 2. between 18 to 50 years old 3. body mass index of 18 to 30 kg/m2 exclusion criteria: 1. acute or chronic medical illness 2. abnormal lung function positive for hiv, hepatitis b or c 3. any significant abnormality of the nose or nasopharynx

Keywords: viral diseases antiviral paramyxoviridae infections rsv aviragen therapeutics, inc. aviragen therapeutics aviragen
alcohol and violence prevention for college students

Conditions: Alcohol Drinking; Sexual Assault

Summary: heavy episodic drinking and sexual assault (sa) are problematic on college campuses. this project will adapt already developed interventions targeting alcohol use and sa to a mhealth format and involve content that incorporates federal guidelines and cdc recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.

specific aims are as follows: aim 1 (stage ia): modify alcohol and sexual assault prevention (asap) content to an ehealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities). aim 1a: assess normative behaviors (n = 500) regarding alcohol use and sa for feedback. aim 1b: adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group \[n=5 from each group\]). aim 2 (stage ib): open pilot trial. obtain usability of asap among 30 students who engage in hed (10 from each risk group) in an open pilot trial. aim 3 (stage ib): a pilot to assess effect size and variability for planning a randomized trial in the future. randomize students who engage in hed to asap or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. sample size was determined to estimate the variability within a reasonable margin of error. this calculation also accounted the low base rates of sa and 20% attrition. this led to a sample size of 162 students (n=54 from each risk group).

Eligibility criteria:
inclusion criteria: * 18-25 years old * current student at university of study * valid email address at university of study * endorse engaging in heavy episodic drinking at least once in the past month on the screening survey exclusion criteria: * there are no exclusion criteria other than not meeting inclusion criteria